MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PSN PK CMT TIB LM SZ E SF; PROSTHESIS KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 08/31/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Location unknown.

Event Description

It was reported the patient had tibial plateau fracture approximately 10 days post partial knee arthroplasty.Currently the patient is being treated non-operatively.

Manufacturer Narrative

(b)(4).Date of event : unknown date in (b)(6) 2018.(udi): n/a.Concomitant medical products : catalog #: 42558000301, partial femur cemented size 3 left medial, lot # 63856141, catalog #: 42529900301, articular surface inserter tip do not implant, lot # 64014021, catalog #: 42518200508, partial articular surface left medial size e 8 mm thickness, lot # 63748324, catalog #: 00598304048, headed screw 48 mm length, lot # 64098461, catalog #: 00598304033, headed screw 33 mm length, lot # 64080491, catalog #: 00598304048, headed screw 48 mm length, lot # 64102708.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed via x rays.Review of the provided x-ray confirmed the presence of a medial tibial plateau fracture.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: PSN PK CMT TIB LM SZ E SF
• Type of Device: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7975570
• MDR Text Key: 124064948
• Report Number: 0001825034-2018-09802
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: K161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42538050501
• Device Lot Number: 63829589
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR